Testing is a crucial part of all software development. If you don't believe this you are likely just starting your career or haven't had to support an application in production with users. It becomes doubly important in a regulated environment. This is because testing for regulated software serves multiple purposes. There is the usual software product development reasons to consider (i.e. professional integrity and no one wants a bug in production). But it is also because the FDA, in particular, wants to make sure you are performing validation and verification of the software. Verification (Was the product built right?) Validation (Was the right product built?) While I acknowledge there are a number of useful and important ways to describe software testing techniques, I strive to keep things simple, and understandable, by the whole team. To that end, I split testing into two tracts: Functional and Technical . Functional is about bring business value to the ...
